1. Field of the Invention
The present invention relates to an ostomy appliance comprising a body side member comprising an adhesive wafer for securing the appliance to a user's skin, said wafer having a hole for receiving a stoma, and a separately exchangeable receiving bag secured to the body side ostomy member for receiving fluids or excretions emerging from an abdominal stoma and a sealing member for sealing between a stoma and an ostomy body side member.
In connection with surgery for a number of diseases in the gastrointestinal or urinary tract a consequence is, in many cases, that the colon, the ileum or the ureter has been exposed surgically and the patient is left with an abdominal stoma, or, in nephrostomy or ureterostomy, the ureter or a catheter is exposed in the back or the chest region or abdominal region, and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma/ureter/catheter. Also in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.
Ostomy appliances are well known. Such appliances may be two-piece or one-piece appliances. In both types of appliances, an adhesive barrier member (or base plate) is attached to the wearer's abdomen/back/chest. In case of a one-piece appliance, a receiving member or bag is attached to the base plate. In case of a two-piece appliance, the adhesive barrier member forms part of a body side member and a receiving member or bag is attached releasably to the body side ostomy member for receiving exudates from the stoma.
When using one-piece appliances, the whole appliance, including the adhesive skin barrier securing the appliance to the skin is normally removed and replaced by a fresh appliance. When using two-piece appliances, the body side ostomy member is left in place up to several days, and only the receiving member or bag attached to the body side member is replaced. The attachment means for attaching an ostomy receiving bag may e.g. be a system se comprising matching coupling rings or matching flanges and adhesive surfaces engaging with and sealing against a flange area of the body side member.
2. Description of the Related Art
Published International Patent Application No. WO 98/17212 discloses an ostomy appliance comprising a body side member comprising an adhesive wafer or pad for securing the appliance to the user's skin, said wafer or pad having a hole for receiving a stoma, and an optionally separately exchangeable receiving member or bag secured to the body side ostomy member for receiving secretions from the ostomy said ostomy appliance further comprising a separate sealing member disposed in the hole of the wafer or pad surrounding the stoma, said sealing member being of a hypo-allergenic adhesive and being in the form of a mouldable mass or a ring.
Published International Patent Application No. WO 00/49981 discloses an ostomy appliance comprising a body side member, an optionally separately exchangeable receiving member or bag secured to the body side member, said body side member comprising a ring-shaped body having an adhesive wafer having a hole for accommodating a stoma and further a separate sealing member is in the form of a disc which, when in use, is placed in the hole for sealing against the stoma, wherein the disc has an outer diameter smaller than the diameter of the hole of the wafer or pad of the ostomy body side member and a flange member stretching from its outer rim, and wherein the flange has outer dimensions greater than the diameter of the hole of the body side member for coupling to the body side member.
Published International Patent Application No. WO 98/53771 also discloses an ostomy appliance comprising a body side member comprising an adhesive wafer or pad for securing the appliance to the user's skin, said wafer or pad having a hole for receiving a stoma, and an optionally separately exchangeable receiving member or bag secured to the body side ostomy member for receiving secretions from the ostomy said ostomy appliance further comprising a sealing member disposed in the hole of the wafer or pad surrounding the stoma wherein the sealing member disposed in the hole of the wafer or pad surrounding the stoma, said sealing member having a hole for accommodating the stoma and said sealing member having balanced plastic and elastic properties allowing an adaptation of the hole of the ostomy appliance to a stoma by a temporary enlarging the hole by everting or rolling up the inner rim of the hole for accommodating the stoma.
Published International Patent Application No. WO 98/53772 discloses an ostomy appliance comprising a body side, member comprising an adhesive wafer or pad for securing the appliance to the user's skin, said wafer or pad having a hole for receiving a stoma, and an separately exchangeable receiving member or bag secured to the body side ostomy member for receiving secretions from the ostomy said ostomy appliance further comprising a separate sealing member disposed in the hole of the wafer or pad surrounding the stoma wherein the separately exchangeable receiving member or bag is secured releasably to the body side ostomy member by a mechanical fastening means.
Although the above references disclose the use of a separate sealing member there is still need of a separate sealing member that may be used together with conventional two-piece ostomy appliances in order to allow an extension of the service time of the body side member for use with an increased number of receiving bags and thus reduce the frequency of stressing the skin around the stoma due to exchange of the body side member by protecting the surface of the adhesive wafer from soiling by and attack from the aggressive visceral contents and facilitating the cleaning of the body side member. Furthermore, there is a need of an improved protecting sealing member improving the safety and quality of life of ostomates having an active social life without having to carry both fresh collecting bags and fresh sealing members while being out of the daily whereabouts.